The New York Milk Bank, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

The New York Milk Bank, Inc. has 1 FDA recall, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "The New York Milk Bank, Inc." is on file.

What these totals cover: FDA records filed under the name "The New York Milk Bank, Inc." and its spelling variant "New York Milk Bank".

Latest recall
H-0308-2026 · Class II · Nov 11, 2025
Latest inspection
Jan 16, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent recalls

1 recall record on Nov 11, 2025.

NumberClassProductDate
H-0308-2026Class IIPasteurized Donor Human Milk in 4 ounce/120 ml clear plastic bottles. The bottles have a foil seal…Nov 11, 2025

Recent FDA inspections

1 inspection on Jan 16, 2025.

DateSiteProductClassificationFEI
Jan 16, 2025Valhalla, NYFood/CosmeticsNo Action Indicated (NAI)3015119380
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3015119380Valhalla, NY1Jan 16, 2025

The New York Milk Bank, Inc. and the FDA: common questions

Has The New York Milk Bank, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "The New York Milk Bank, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has The New York Milk Bank, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "The New York Milk Bank, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect The New York Milk Bank, Inc.?

The most recent FDA inspection on file ended Jan 16, 2025 at Valhalla, NY and was classified NAI. FDA has 1 inspection of The New York Milk Bank, Inc. on file.

Has The New York Milk Bank, Inc. had an FDA recall?

Yes. The New York Milk Bank, Inc. has 1 FDA recall on record. The most recent started Nov 11, 2025.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.